Cleared Special

ST AIA-PACK CEA ENZYME IMMUNOASSAY

K023893 · Tosoh Medics, Inc. · Immunology
Dec 2002
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K023893 is an FDA 510(k) clearance for the ST AIA-PACK CEA ENZYME IMMUNOASSAY, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 18, 2002, 26 days after receiving the submission on November 22, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K023893 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2002
Decision Date December 18, 2002
Days to Decision 26 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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